Kendall SCD 74022 (UDI 10884521130869)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884521130869), received between Jun 19, 2019 and Mar 11, 2021 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Human-Device Interface Problem” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMar 11, 2021Human-Device Interface Problem; Human-Device Interface Problem

  THE CUSTOMER REPORTED WHEN THEY PUT THE SLEEVE ON THE PATIENT'S LOWER LEG AFTER A SURGERY, THE SKIN TURNED RED ALONG THE INNER BLUE HUMAN PRINT. THE PATIENT WAS TREATED WITH AN UNKNOWN OINTMENT.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 11464266 ↗
• MalfunctionJan 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED A DERMATITIS OCCURRED ON THE PATIENT USING THE SLEEVE AFTER SURGERY. THE PATIENT GOT A RED RASH IN THE SHAPE OF HUMAN ON BOTH LEGS. THE PATIENT WAS PRESCRIBED 0.05% ANTEBATE OINTMENT + VASELINE, 25% HYCHEE GRANULES TO TREAT THE RASH.

  Patient problems: Rash

  MAUDE report 11132087 ↗
• InjurySep 15, 2020Use of Device Problem; Use of Device Problem

  THE CUSTOMER REPORTED THAT A HEMATOMA WAS FOUND ON THE LEFT CALF OF THE PATIENT AFTER REMOVING THE SLEEVE FROM THE PATIENT WHEN CHANGING THE PATIENT'S BODY POSITION.

  Patient problems: Hematoma

  MAUDE report 10535526 ↗
• InjuryJun 19, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE CUSTOMER REPORTS DURING SURGERY FOR COLORECTAL CANCER, COMPARTMENT SYNDROME HAS OCCURRED IN THE PATIENT USING THE SCD COMFORT SLEEVE. ADDITIONAL INFORMATION RECEIVED ON 16-JUL-2019 STATES THAT THE COMPARTMENT SYNDROME WAS LOCATED IN THE RIGHT LOWER LEG OF THE PATIENT RIGHT AFTER SURGERY. THE SLEEVES WERE PLACED BEFORE SURGERY. THE PROCEDURE LASTED FOR 3 HOURS AND 30 MINUTES AND DID NOT INVOLVE ANY PART OF THE PATIENT¿S LEG. THE SLEEVES AND SCD WERE ON THE PATIENT FOR 3 HOURS AND 30 MINUTES. SKIN/EXTREMITY ASSESSMENT WAS PERFORMED BEFORE AND AFTER SURGERY BUT NOT DURING SURGERY. MEDICAL INTERVENTION REQUIRED RELIEF INCISION. ADDITIONAL FOLLOW UP TREATMENT WILL BE REQUIRED BECAUSE THE WOUND AFTER THE RELIEF INCISION SURGERY HAS NOT CONNECTED BECAUSE OF NECROSIS. THE PATIENT DID NOT HAVE ANY LEG OR SKIN CONDITIONS PRIOR TO USE. THE ONLY MEASUREMENT DONE PRIOR TO SURGERY WAS THE LENGTH AROUND THE ABDOMEN. THE PATIENT CAN WALK COMPLETELY.

  Patient problems: Tissue Damage

  MAUDE report 8711597 ↗